1. Planning and managing day to day analysis of received samples. Ensuring on time release of received samples for the products in Quality control dept. and Microbiology dept.
2. Conduct routine and nonroutine analyses of inprocess materials raw materials packing materials finished goods or stability samples for Invitro Diagnostic Large volume parentals and Cytobiologics manufacturing products.
3. Devising improving and reviewing new specifications and procedures for products or processes and training staff to use them.
4. Perform the quality inspection process of new part samples and record the data.
5. Interpret test results compare them to established specifications and control limits and make recommendation on appropriate ness of data release.
6. Investigate customer complaints regarding quality issues and develop a solution.
7. Record compile and prepare report for analysis and evaluation.
8. Observing and complying with GxPs GLP GMP and GDP.
9. Assist in auditing writing revising and verifying quality standard and developing forms and instruction for recording and reporting quality data.
10. Monitoring performance of quality control system to ensure effectiveness and efficiency.
11. Participate in the development of product specifications and analytical Method validation of products.
12. Gaining an understanding of the clients needs and requirements and communicating them and the quality standards to the production teams.
13. Ensuring that all activities are performed in accordance with GMP company SOPs and Health and Safety policies.
14. Gaining knowledge of all cGMP rules and regulations and develop a system of effectively implementing them according to written guidelines.
15. Preparation of validation protocols of new instrument installed in Quality Control Laboratory.
16. Handling and Investigation of OSS OOT results change control Incidents Deviations and CAPA related to QMS.
17. Ensuring cooperation between all department for Smooth workflow.